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Tag Archives: Medical Plastics

I began working with Orthopedic medical device manufacturers in the late 90’s . Back then we had the typical materials for the Orthopedic industry. Those included PPSU, PEI, PP, PE, POM-C and of course UHMW. The applications utilizing these materials were all pretty much the same: provisional trials for knees hips and shoulders, instrumentation handles, impactors, bearings and implants amongst other applications. In many industries we hear about new materials being developed on a regular basis, but in medical it almost seems time is standing still. Where’s the innovation for medical device applications?

Polymer Technologies for Medical Remain Virtually Unchanged

Not a lot has changed over the years on the Polymer side to really catapult plastics into a place up there with the Ti Eli’s and CoCr of their alloy counterparts. Sure, we’ve seen a nice niche’ for Heat Stabilized Polypropylene used in Surgical Caddies and some filled materials primarily BaSO4 used in PPSU and PEI, so they are radio opaque and are visible under X-Ray. We’ve also seen some of the carbon fiber composites with a PAEK base adopted in a variety of roles from targeting guides to external fixation devices.

Let’s not forget about PEEK either, which has played a significant role in medical devices for the past 15 years. Unfortunately the majority of the applications for that material are for implants. Although there have been a variety of other applications using PEEK that are not of the implantable variety, utilizing PEEK that is approved for 24 hour direct contact with the body has only begun to flourish over the last few years. PEEK Classix which is approved for human implant up to 30 days has also seen a dramatic rise in popularity not only in Orthopedic, Spine and Trauma applications but dental applications as well. But Implant Grade PEEK per ASTM F2026 has really been the most popular of all of the medically approved PEEK variations with spinal cages being far and away the biggest reason for that.

The current state of medical plastics innovations leads to many questions. When is the next generation of FDA approved (Cl. VI/ ISO:10993) polymers going to debut? What will those breakthrough materials be?

Why has it been so long since we have seen innovations in polymer materials for medical use?
– Is it because of the fear of the liability risk?
– Is all the requisite testing that is involved in bringing that kind of innovative polymer to market holding up efforts?
– Have scientists not yet developed a material that can compete in price and performance to a PEEK or PPSU?
– Will the next generation of polymer be a quantum leap supplanting current materials that have been mainstays in the market like a PPSU?
– Will it offer not only compressive and tensile strengths to compete with our alloy counterparts but the elastic modulus and lightweight performance that the market demands? I for one, am hopeful that will be the case.

On Another Related Note, Let’s Talk About how the FDA may Be Impacting the Development of Materials for Medical Applications

In July/August of 2012 the FDA submitted new guidance for “Acceptance and Filing Reviews of Pre-Market Approval (PMA) Acceptance” for Medical Devices and in Dec 2012 / January2013 this new guidance was implemented. With the new guidance the FDA has put greater emphasis on qualifying that all materials are safe and effective in the way they are used in the application. Plastics being a major component used in many surgical procedures are now required to be fully qualified where they may not have been in the past. Some of the main concerns of plastics being used is not necessarily what the chemical composition or molecular chain is, but rather, what exactly is in them? We know that PPSU is used in medical procedures and can have direct body contact of bone, blood and tissue . The real question beyond that is what makes that material blue, brown or green?
– Are the compounds that turn that naturally amber PPSU blue, safe and effective?
– Does that material meet the FDA requirements for percentages by weight and have those specific compounds and percentages been tested to show they are safe for the general public?
The onus of proving these things out does not fall in the laps of the FDA it falls in the laps of the device manufacturers, the material suppliers, the shapes producers and the resin manufacturers. The device market has good reason to be concerned as well. They want to ensure they are putting out safe, reliable and effective products. The last thing they need is a product recall or worse a class action lawsuit. We know that plastics provide many benefits including lighter weight, wear resistance, chemical resistance and more and as I see developments in other industries I look toward the future of new plastics for medical devices with great hope and I hope you will too.

Medical Device Manufacturers Delaying new Projects and Increasing Layoffs due to Unease Over Multiple IssuesThe medical device manufacturers have had a volatile year so far with the impending device excise tax slated for 2.3% of total revenues generated to start 2013. In anticipation of this new tax many companies have delayed product development as well as New Product Introduction (NPI) until after the Presidential election in hopes that there is more clarity in regards to the excise tax. Jitters within the EU have also contributed an overall uneasiness within the industry. Major medical device companies like Stryker have already begun workforce reduction to the tune of 1,000 global employees from their workforce in the Orthopedics division with an estimated cost savings of approximately $100 million. Former Stryker CEO Steve MacMillan in November of 2011, estimated the new tax will add an additional $150 million to their tax liabilities. On Thursday, June 28, 2012 a spokesperson for Stryker stated that the added tax will eat into approximately one third of their R&D budget. Other companies such as Medtronic announced they will reduce their workforce by 1,000 employees globally across many of their business units, Smith and Nephew, and Covidien have also announced layoffs that began taking effect in 2011 and/or 2012 (see the Wall Street Journal for more) With the House of Representatives recently passing legislation (Health Care Cost Reduction Act H.R. 436) and the decision by the Supreme Court on the Patient Protection and Affordable Care Act signed into law in 2010 by President Obama the excise tax slated for January 1, 2013 is starting to look like a reality. At this point it appears that the big guys are setting themselves up to operate more effectively and efficiently with expectations of continuing to meet market demands, while also trying to maintain the quality standards that are required. Who in your eyes are the best positioned companies as we move forward? Can you really reduce headcount without having a detrimental affect on quality? With yesterday’s ruling I think it is very likely we will see even more layoffs as the industry attempts to reduce staff to offset the additional tax liabilities.

The Upside to the Shifting Medical Device Industry
In addition to the health care reform debate and the recent Supreme Court ruling, mergers and acquisitions have also played a large roll in making this a volatile year as large medical conglomerates continue to acquire competitors in order to balance and strengthen their portfolios and focus on areas where they currently do not have a strong market share position. Most notably the acquisition of Synthes by J&J (DePuy) for $21.3 billion, strengthening their brand in the Spinal, Trauma and CMF segments. The deal which was approved by the FTC on June 11, 2012 with a provision that it divest its wrist fracture system (DVR ) to Biomet. (see FTC article) Without the sale, the new Synthes/Depuy portfolio for Distal radial fracture devices would have had 70% market share. Synthes is the market leader for these systems with an estimated 42% market share, Biomet also previously agreed to acquire Depuy’s trauma unit for an estimated $300 million. (click here to see Johnson & Johnson’s article) I believe we will continue to see market consolidation through the remainder of 2012 and through 2013 with a major focus on Chinese manufacturers being acquired for easier penetration into this emerging market for devices. Other notable acquisitions: Asahi Kasei acquired Zoll medical ($300 million). Symmetry medical acquired Codman ($300 million) and Stryker acquired Orthovita for ($316 million), Memometal in France ($150 million) and Boston Scientific’s neurovascular unit ($1.45 billion).

Speaking of China…With yesterday’s ruling by the Supreme Court to uphold the Patient Protection and Affordable Care Act, will we begin to see even more business transition over to China? Will it be India? How about Africa, where many of the MRO Aerospace operations have sprung up. Is this an option for the medical device industry? Will R&D transition over to Asia at a faster pace than was originally planned for these corporations? Not only did the device industry take a hit yesterday, but its been a tough week with the Senate passing the User Fee Act for Medical device manufacturers increasing it from $295 million over the last five years to $595 million over the course of the next five years. What’s $595 million over five years for the device industry? We shall see, it should be an interesting run up to the election and an even more interesting time after the general election.

What will Happen to the Growth we Have Seen?Although there has been little in the way of growth for most of the last 12 months in the medical device industry, there are some fairly sizable product developments churning at some of the larger OEM’s. There have also been some key innovators that have popped up over the last 36 months. Will these new guys set new market trends and turn into a preeminent market leader on a new system or device? Will the innovators be the ones that help turn around domestic manufacturing or will they be gobbled up by one of the big guys that is looking to acquire some IP to add to its portfolio and then shift the manufacturing offshore? We are in interesting times, how will it all shake out? Stay tuned, we will find out sooner rather than later and as things happen I will do my best to bring the facts to light so everyone can stay informed about changes to this very important industry.

Mike Farran, AIN Plastics Corporate Buyer for TYGON® with the Distributor of the Year Award. Mike recently took over for Lydia Gonzalez who has moved to a new position within AIN. Mike says he plans to continue the success begun by Lydia and to bring home the award to AIN again this year!

We carry a lot of different kinds of plastic products as well as ancillary items. But we don’t just toss things on our shelves and look for buyers. We really enjoy what we do and to that end we strive to be experts when it comes to the products we sell. We want to find the best products out there and deliver them at the best possible prices. We also want to be able to answer customer questions when they need help with products so that we offer the best product and service experience all the way around. This year we received a great honor from Saint-Gobain Performance Plastics for our support and sales of their TYGON® products. The Saint-Gobain Performance Plastics, “Distributor of the Year” is awarded annually and is based on meeting the criteria of the TYGON® Elite Channel Partner Program sales and marketing objectives.

Mike Block, Channel Manager at Saint-Gobain Performance Plastics stated, “Saint-Gobain Performance Plastics is pleased to present our TYGON® Elite 2011 Distributor of the Year award to AIN Plastics, for their outstanding achievements in the promotion of the TYGON® brand over the past year. As one of our “Elite” channel partners, AIN Plastics continues to remain a major contributor to the advancement of the TYGON® brand name. AIN Plastics continues to play an important role in our marketing efforts by providing technical expertise, new business development, comprehensive stocking programs and customer service support for TYGON® application specific tubing. We value the relationship, the motivation to achieve results, and the professionalism we enjoy in working with these fine people.”

“AIN Plastics is honored to be named Saint-Gobain Performance Plastics Distributor of the Year,” stated John Shepherd, President at AIN Plastics. “Our partnership with Saint-Gobain Performance Plastics has provided many opportunities for both of our organizations over the years, and we are excited for the future growth we foresee with this quality solutions manufacturer.”

Saint-Gobain Performance Plastic’s partnership with AIN Plastics supports many business to business sales transactions in focus markets throughout North America. AIN Plastics, Division of ThyssenKrupp Materials NA is based in Madison Heights Michigan and has locations all across the United States. Our network of locations allows us to easily service customers throughout North America.

Performance Plastics. These products are used in Food and Beverage, Chemical, Industrial, Habitat, Micro Electronics, Document Processing, Pharmaceutical, Bio Technology and Medical applications for the worldwide market. For more information on TYGON® Products from AIN Plastics visit the TYGON® pages on our site or for more about AIN Plastics, Division of ThyssenKrupp Materials NA visit our website at www. ainplastics.com

About Saint-Gobain Performance PlasticsSaint-Gobain Performance Plastics manufactures standard and custom TYGON® tubing, engineered thermoplastics and flexible hoses worldwide for diverse markets, including chemical, industrial, food and beverage, habitat, and medical. The company is headquartered in Aurora, Ohio, and has manufacturing facilities in France, Germany, China and India. For more information, visit us at www.processsystems.saint-gobain.com